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# Monoclonal Antibody Manufacturing Changes Research
- URL: https://www.fdaweb.com/monoclonal-antibody-manufacturing-changes-research/
- Published: 2023-11-02T12:00:00.000Z
- Updated: 2026-09-14T14:15:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155713

Three CDER Office of Clinical Pharmacology researchers say their comprehensive retrospective analysis of the data supporting manufacturing changes for licensed monoclonal antibodies and Fc-fusion proteins “provides an understanding of the regulatory experience and industry practice, which could facilitate developing appropriate comparability approaches to support manufacturing changes in the future.” Writing in *Pharmaceutical Research*, the researchers [say](https://link.springer.com/article/10.1007/s11095-023-03627-5?ref=fdaweb.com) (purchase required) they surveyed the manufacturing changes of 85 monoclonal antibodies and 10 Fc-fusion proteins approved by FDA as of 12/25/21.

They investigated the approaches that provided supporting data for the changes and analytical comparability data to support all identified manufacturing changes. The researchers report that supporting clinical data were available in 92% of the manufacturing changes, including data from pharmacokinetic comparability studies alone (3%), other studies on efficacy or safety (70%), and a combination of both (19%).

“Clinical pharmacokinetic comparability data contributed to supporting substantial changes, such as host cell type or master cell bank changes, concentration or formulation changes, and changes from pre-filled syringes to autoinjectors, especially when introduced after completing pivotal studies,” the researchers write.